Expert Scientific Group on Phase One Clinical Trials final report

9780117037229: Expert Scientific Group on Phase One Clinical Trials final report

This particular Expert Scientific Group was established following the very serious adverse reactions that occurred in the first-in-man clinical trial (that is the first time the drug is given to a human) of TGN1412 in March 2006. The trial was performed in a private clinic research unit at Northwick Park Hospital in London. TGN1412 is a monoclonal antibody that was being developed as a medicine to treat leukaemia and autoimmune diseases such as rheumatoid arthritis. In the clinical trial, six healthy male volunteers experienced severe systemic adverse reactions soon after receiving TGN1412 intravenously. All six volunteers developed a cytokine (small protein molecules that transmit signals between immune cells and tissue cells) release syndrome with multi-organ failure and required intensive treatment and supportive measures. The Expert Group states that the pre-clinical development studies that were performed with TGN1412 did not predict a safe dose for use in humans, even though current regulatory requirements were met. The Expert Scientific Group has set out 22 recommendations that should increase the safety of volunteers in future clinical trials, and these cover the following areas: the preclinical and early clinical development; the process of preparation and review of clinical trial applications, and early access to advice for both regulators and sponsors; the determining and administering of the initial doses in man; the clinical environment for first-in-man studies and the development of the skills and training to meet future needs.

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